Trinity Term [2017] UKSC 48 On appeals from: [2015] EWCA Civ 555 and 556

JUDGMENT
Actavis UK Limited and others (Appellants) v Eli
Lilly and Company (Respondent)
Eli Lilly and Company (Appellant) v Actavis UK
Limited and others (Respondents)
Eli Lilly and Company (Appellant) v Actavis UK
Limited and others (Respondents)
before
Lord Neuberger, President
Lord Mance
Lord Clarke
Lord Sumption
Lord Hodge
JUDGMENT GIVEN ON
12 July 2017
Heard on 4, 5 and 6 April 2017
Actavis and others Eli Lilly and Company
Daniel Alexander QC Thomas Mitcheson QC
Thomas Raphael QC Andrew Waugh QC
Isabel Jamal Stuart Baran
(Instructed by Bird & Bird
LLP
)
(Instructed by Hogan
Lovells International LLP
)
Page 2
LORD NEUBERGER: (with whom Lord Mance, Lord Clarke, Lord
Sumption and Lord Hodge agree)
1. The issue raised on this appeal and cross-appeal is whether three products
manufactured by the Actavis group of companies (“Actavis”) would infringe a
patent whose proprietor is Eli Lilly & Company (“Lilly”), namely European Patent
(UK) No 1 313 508 (“the Patent”), and its corresponding designations in France,
Italy and Spain.
2. This judgment was circulated in draft to the parties’ legal representatives in
the normal way on 5 July 2017, on the basis that it would be handed down a week
later. On the following day, just after midday, Actavis’s solicitors emailed the Court
expressing concern about the potential prejudice which their clients could suffer if
they did not know of the outcome of this appeal until 12 July. Not least because
publication of our decision could have an effect on the share prices of Actavis or
Lilly or both of them, the Court proposed to the parties’ respective solicitors that we
should announce our decision at once, while maintaining the intention, in
accordance with this Court’s usual practice, to hand down the judgment a week after
circulation of the draft. This was agreed by both solicitors, and accordingly on 7 July
at 11.30 am, the following announcement appeared on the Court’s website:
“The Supreme Court allows Eli Lilly’s appeal and holds that
Actavis’s products directly infringe Eli Lilly’s patent in the
United Kingdom, France, Italy and Spain. The Court dismisses
Actavis’s cross-appeal on the basis that if its products did not
directly infringe, they would indirectly infringe to the extent
held by the Court of Appeal.”
Accordingly, these are technically the reasons for those conclusions.
The factual and technical background
The factual background
3. Pemetrexed is a chemical which has been known for some time to have
therapeutic effects on cancerous tumours. However, when used for that purpose on
its own, pemetrexed can often have seriously damaging, sometimes even fatal, sideeffects. Accordingly, its use as an anti-cancer drug was effectively precluded in
Page 3
practice. The essential disclosure of the Patent was that the damaging side-effects
could largely be avoided if a compound called pemetrexed disodium was
administered together with vitamin B12. This has enabled pemetrexed disodium to
be used for treatment in the form of a medicament which includes the vitamin. Such
a medicament has been successfully marketed, under the brand name Alimta, by
Lilly since 2004.
4. The Patent primarily claims the use of pemetrexed disodium in the
manufacture of a medicament for use in combination with vitamin B12 (and,
optionally, folic acid) for the treatment of cancer.
5. Pemetrexed itself is a member of a class of chemicals known as antifolates,
and its molecular structure is shown below, with C, N, O and H being respectively
the chemical symbols for carbon, nitrogen, oxygen and hydrogen; and the
unallocated points on the chains and the rings being carbon.
6. The presence of the two -CO2H units results in pemetrexed being an acid
(hence it is also known as pemetrexed diacid), or as it is sometimes called, a free
acid. When pemetrexed is dissolved in water, the hydrogens in those two units
separate from the rest of the molecule as positively charged entities, protons, and
the rest of the molecule becomes a negatively charged entity called an anion. The
structure of pemetrexed disodium is similar except that, instead of the two -CO2H
units, it has two -CO2Na units (Na being the symbol for sodium). Pemetrexed
disodium dissolves in water, where the two sodiums separate from the rest of the
molecule as positively charged entities called cations, and the rest of the molecule
becomes an anion. Because it is the pemetrexed anion which is of interest, the
sodium cation is often referred to as a counter-ion. A substance such as pemetrexed
disodium, where the acidic hydrogens have been replaced, is known chemically as
a salt.
7. Although one might have thought that the actual invention should have been
characterised as a disclosure that pemetrexed could be administered safely if it was
combined in a medicament with vitamin B12, the claimed invention in the Patent is,
Page 4
as mentioned in para 4 above, the manufacture of such a medicament. This
formulation was required by the then-prevailing law contained in article 52(4) of the
European Patent Convention 1973 (“EPC 1973”), which prohibited from
patentability any method of treatment of humans or animals. This led to inventions
which otherwise might have been expected to be expressed as being new therapeutic
treatments being cast as manufacturing claims. Such claims are known as Swiss
form claims, and they were illuminatingly discussed by Kitchin J in Ranbaxy (UK)
Ltd v Astrazeneca AB [2011] FSR 45, paras 42 to 60. As he explained, the
prohibition was substantially modified in article 53 in the European Patent
Convention 2000 (“EPC 2000”), but that modification had not come into force when
Lilly applied for the Patent.
8. Actavis’s proposed products involve pemetrexed compounds being used
together with vitamin B12 for cancer treatment. However, rather than pemetrexed
disodium, the active ingredient in those products (“the Actavis products”) is (a)
pemetrexed diacid, (b) pemetrexed ditromethamine, or (c) pemetrexed dipotassium.
In other words, rather than including the disodium salt referred to in claim 1 of the
Patent, the Actavis products include as the active ingredient (a) pemetrexed itself (ie
the free acid), or pemetrexed with the hydrogens on the two -CO2H units replaced
by (b) tromethamine, or (c) potassium. Actavis contend that, because they intend to
use the Actavis products which do not include pemetrexed disodium, the claims of
the Patent, which are expressed as involving the use of pemetrexed disodium, would
not be infringed. By contrast, Lilly contends that there would be either direct or
indirect infringement of the Patent if Actavis launch any of the Actavis products on
the market in the UK or in France, Italy, or Spain. The allegation of direct
infringement is based simply on the proposition that marketing or use of the Actavis
products would infringe the Patent; indirect infringement is said to arise because
pemetrexed disodium is claimed to be involved in the preparation of the Actavis
products before they are administered.
9. After a four-day trial, Arnold J decided that none of the Actavis products
would directly or indirectly infringe the Patent in the UK or in France, Italy or Spain
– [2015] Bus LR 154; [2015] RPC 6. The Court of Appeal allowed Lilly’s appeal to
the limited extent of holding that there would be indirect infringement in the four
jurisdictions, but they agreed with the Judge that there would be no direct
infringement – [2015] Bus LR 1068. Lilly appeals against the rejection of its case
that there would be direct infringement, and Actavis cross-appeal against the
rejection of their case that there would be no indirect infringement.
10. As Floyd LJ explained in the Court of Appeal, the appeal raises the issue of
the correct approach under UK law (and the law of the three other states) to the
interpretation of patent claims, and in particular the requirement of EPC 2000 to take
account of “equivalents”, and also the extent to which it is permissible to make use
of the prosecution history of a patent when determining its scope. The issue on the
Page 5
cross-appeal is rather more fact-specific, namely whether the application of the law
of contributory infringement justifies a finding of indirect infringement in this case.
11. It is appropriate to start by setting out the relevant provisions of the Patent
and the knowledge of its assumed addressee, topics on which my account is largely
taken from the clear judgment of Floyd LJ in the Court of Appeal. I will then turn
to the issue of direct infringement, which involves considering the proper approach
to that issue generally, and also the relevance of the prosecution history. I will then
consider the position in the three other states and finally I will address the issue of
indirect infringement.
The specification and claims in the Patent
12. The Patent is entitled “Combination containing an antifolate and
methylmalonic acid lowering agent”, and it has a claimed priority date of 30 June
2000.
13. The specification begins at para [0001] by stating that “[p]otentially, lifethreatening toxicity remains a major limitation to the optimal administration of
antifolates”. It then explains at para [0002] that antifolates work by inhibiting antifolate-requiring enzymes by competing with reduced folates for binding sites on
those enzymes. The specification identifies several antifolate drugs as being in
development, including Lilly’s branded product Alimta.
14. The specification then explains at para [0003] that a limitation to the
development of these drugs is that they may be associated with substantial toxicity,
including mortality, for some patients. These toxicity effects had led to the
abandonment of the development of some antifolates. In para [0004] the
specification explains that previous work had been done on the use of folic acid as
a treatment for toxicity in this area. It also records work on vitamin B12 as a
predictor of cytotoxic events.
15. The specification then states in para [0005]:
“Surprisingly and unexpectedly, we have now discovered that
certain toxic effects such as mortality and non-hematologic
events, such as skin rashes and fatigue, caused by antifolates,
as a class, can be significantly reduced by the presence of a
methylmalonic acid lowering agent as vitamin B12, without
adverse adversely affecting therapeutic efficacy. The present
invention thus generally relates to a use in the manufacture of
Page 6
a medicament for improving the therapeutic utility of antifolate
drugs by administering to the host undergoing treatment with a
methylmalonic acid lowering agent as vitamin B12.”
16. Para [0006] of the specification continues:
“Additionally, we have discovered that the combination of a
methylmalonic acid lowering agent as vitamin B12 and folic
acid synergistically reduces the toxic events associated with the
administration of antifolate drugs. Although, the treatment and
prevention of cardiovascular disease with folic acid in
combination with vitamin B12 is known, the use of the
combination for the treatment of toxicity associated with the
administration of antifolate drugs was unknown heretofore.”
17. These early, general statements are made in relation to antifolates as a class.
However, at para [0010] the specification says, in what is known as a consistory
clause, that the invention:
“specifically provides the use of the antifolate pemetrexed
disodium in the manufacture of a medicament for use in
combination therapy for inhibiting tumour growth in mammals
wherein said medicament is to be administered in combination
with a methylmalonic acid lowering agent selected from
vitamin B12 and pharmaceutical derivatives thereof.”
18. Having referred specifically to pemetrexed disodium, the specification
reverts to generality at para [0016], where it states:
“The current invention concerns the discovery that
administration of a methylmalonic acid lowering agent such as
vitamin B12 or a pharmaceutical derivative thereof, in
combination with an antifolate drug such as pemetrexed
disodium reduces the toxicity of the said antifolate drug.”
19. Para [0022] contains a definition:
“The terms ‘antifolate’ and ‘antifolate drug’ generally refer to
a chemical compound which inhibits at least one key folaterequiring enzyme of the thymidine or purine biosynthetic
Page 7
pathways … by competing with reduced folates for binding
sites of these enzymes. The ‘antifolate’ or ‘antifolate drug’ for
use in this invention is Pemetrexed Disodium (ALIMTA®), as
manufactured by Eli Lilly & Co.”
20. The invention is then illustrated by reference to a number of examples
relating to animal and human tests, in which the only antifolate used is pemetrexed
disodium. At para [0035] the specification states that animals were treated with
“pemetrexed disodium (ALIMTA®) (100 mg/kg or 150 mg/kg) once daily … by
intraperitoneal injection alone or along with folic acid”. The specification also
indicates at para [0044] that, in a typical clinical evaluation using cancer patients,
the antifolate is to be administered in four doses over a two-week period by rapid
intravenous injection.
21. Turning to the claims, it is only necessary for present purposes to refer to
claims 1 and 12, which are in these terms:
“1. Use of pemetrexed disodium in the manufacture of a
medicament for use in combination therapy for inhibiting
tumour growth in mammals wherein said medicament is to be
administered in combination with vitamin B12 or a
pharmaceutical derivative thereof [which it then specifies].”
“12. A product containing pemetrexed disodium, vitamin
B12 or a pharmaceutical derivative thereof said pharmaceutical
derivative [which it again specifies], and, optionally, a folic
binding protein binding agent selected from [a specified group
of chemicals including folic acid], as a combined preparation
for the simultaneous, separate or sequential use in inhibiting
tumour growth.”
The notional addressee of the Patent
22. A patent is interpreted on the basis that it is addressed to a person or group of
persons who is or are likely to have a practical interest in the claimed invention, ie
through the eyes of a person or persons skilled in the art. There is now no challenge
to the Judge’s conclusion that the notional addressee of the Patent would be a group
consisting of an oncologist and a chemist, a conclusion upheld by the Court of
Appeal.
Page 8
23. The Judge found that the common general knowledge of an oncologist as at
the relevant time, 2001/2002, included the following:
i) Antifolates were used in cancer chemotherapy, but their use caused
toxic side effects which it would be desirable to avoid or reduce.
ii) Pemetrexed was the subject of clinical trials for use in chemotherapy,
and it targeted multiple enzymes and was administered intravenously.
iii) The only form of pemetrexed which had been shown to be effective
and safe to any extent was pemetrexed disodium, which was manufactured
by Lilly under the trade mark Alimta.
iv) The characteristics of both vitamin B12 and folic acid were well
understood, and it was well known that there were many different safe and
effective forms of both available.
24. The Judge also concluded that oncologists did not think about drugs such as
pemetrexed in their ionic form, nor did they consider issues regarding the choice of
counter-ion or the effect, if any, of counter-ions on the efficacy, safety or other
properties of the drug. This was the province of the chemist and, because the
properties of different salt forms and free acids were difficult to predict, a chemist
would need to address any such issue by conducting experiments.
25. The Judge made the following findings as to the common general knowledge
of a chemist as at 2001/2002:
i) Where a drug is or is based on an acid, different salts of the parent acid
can be formed by reacting it with a complementary base or acid. The salt will
often have different properties from the parent acid, and different salts will
often have different properties from each other. So, salt screening is a routine
but important exercise in determining the most suitable form of a drug.
ii) The facts set out in paras 5 and 6 above.
iii) Solid salts consist of the anions and cations regularly arranged in a
fixed lattice structure. Because the cations and anions are present in fixed
proportions and in fixed relative positions it is possible to speak meaningfully
of the salt as being present in solid form.
Page 9
iv) When a salt is dissolved in water, the ions dissociate, forming free
cations and anions in solution. Although the salt ceases to exist, it is common
to refer to “a salt solution” or “a salt in solution”.
v) The salt form can have a significant impact on the effectiveness of a
drug in that it can modify many aspects of the drug.
vi) When considering a drug for intravenous chemotherapy, the solubility
of the salt form is crucial, as good solubility is an indicator of how likely it is
that the drug will be absorbed in the gut.
vii) But if a salt is too soluble, it cannot be made in solid form.
viii) In general, there can be many dead-ends and false leads when
attempting to prepare salts of a parent molecule for the first time.
ix) One cannot predict (a) whether one could make a particular salt form
of a parent molecule, (b) what its properties would be once it was made or
(c) whether it would affect the efficacy of the drug.
26. The Judge made specific findings about a chemist’s state of knowledge about
three types of salts and about free acids:
i) Sodium was generally the preferred counter-ion, and so would be first
choice. Sodium salts generally were not toxic, and would be expected to be
reasonably soluble, but they were not always easy to make.
ii) Potassium salts were also generally soluble, but there were exceptions.
There were concerns about the potential toxicity of such salts, which was
particularly significant if large quantities of the drug were involved.
iii) There were only a small handful of examples of tromethamine salts
being used in 2001. It was known that tromethamine salts might well be too
soluble, so one would not be able to make and harvest the solid form.
iv) In principle, the acidic parent molecule could be administered in the
form of the free acid. But it was often necessary to change from the free acid
to a salt form for various reasons including solubility.
Page 10
Direct infringement
27. In a nutshell, the rival contentions are these. Lilly argues that the Actavis
products infringe the Patent because they are medicaments to be used as a treatment
for cancer consisting of pemetrexed diacid, or a pemetrexed salt, with vitamin B12,
which represents the essence of the teaching and claim of the Patent. By contrast,
Actavis argues that their products do not infringe because the claims of the Patent
are limited to a specific pemetrexed salt, namely pemetrexed disodium, and the
Actavis products contain either pemetrexed diacid or different pemetrexed salts.
The legislative context
28. The domestic provision governing direct patent infringement is section 60(1)
of the Patents Act 1977. However, section 130(7) declares that certain provisions of
that Act, including section 60, are “so framed as to have, as nearly as practicable,
the same effects in the United Kingdom as the corresponding provisions of the
European Patent Convention … have in the territories to which [that Convention
applies]”. Accordingly, it is common ground that it is appropriate to consider the
present case by reference to the EPC 2000.
29. Article 69(1) EPC 2000 provides that “[t]he extent of the protection conferred
by a European patent … shall be determined by the claims”, although it is followed
by another sentence, namely “[n]evertheless, the description and drawings shall be
used to interpret the claims”.
30. As a matter of ordinary language, it is quite clear that the only type of
pemetrexed compound to which the Patent’s claims expressly extend is pemetrexed
disodium. One only needs to read claim 1 and claim 12 to justify that: as a matter of
ordinary language, “pemetrexed disodium” means that particular salt, and no other
salt, let alone the free acid. If the first few words of each claim were not enough to
make this good, the contrast between the specific reference to pemetrexed disodium
and the wider reference to “vitamin B12 or a pharmaceutical derivative thereof”
underlines the point. As Floyd LJ said, this conclusion is also supported by what is
said in the specification – eg in paras [0010] and [0022] quoted above. It is fair to
say that para [0016] could be said to point the other way, but it is far too weak a
basis for even arguing that the Patent’s claims extend, as a matter of language, to
pemetrexed compounds other than pemetrexed sodium.
31. In these circumstances, The Protocol on the Interpretation of article 69 as
amended in 2000 (“the Protocol”) is crucial to Lilly’s contention that the scope of
Page 11
protection afforded by the Patent extends to the Actavis products. The Protocol
provides:
“Article 1
General principles
Article 69 should not be interpreted as meaning that the extent
of the protection conferred by a European patent is to be
understood as that defined by the strict, literal meaning of the
wording used in the claims, the description and drawings being
employed only for the purpose of resolving an ambiguity found
in the claims. Nor should it be taken to mean that the claims
serve only as a guideline and that the actual protection
conferred may extend to what, from a consideration of the
description and drawings by a person skilled in the art, the
patent proprietor has contemplated. On the contrary, it is to be
interpreted as defining a position between these extremes
which combines a fair protection for the patent proprietor with
a reasonable degree of legal certainty for third parties.
Article 2
Equivalents
For the purpose of determining the extent of protection
conferred by a European patent, due account shall be taken of
any element which is equivalent to an element specified in the
claims.”
The original Protocol was agreed in 1973; the amendments made in 2000 effected
very slight modifications to what is now article 1, and introduced article 2 for the
first time.
32. The drafting of the Protocol bears all the hallmarks of the product of a
compromise agreement. This is unsurprising. There is an inevitable conflict between
the desirability of giving an inventor an appropriate degree of protection in a
particular case and the need for clarity of principle as to the extent of such protection
generally; and, of course, there is an unavoidable tension between the
appropriateness of giving an inventor a monopoly and the public interest in
Page 12
maximising competition. In addition, the EPC 2000 and the Protocol apply in many
different states which have different traditions and approaches in relation to the law
of patents. In that connection, as the Supreme Court observed in Schütz (UK) Ltd v
Werit (UK) Ltd (Nos 1 to 3) [2013] Bus LR 565; [2013] RPC 16, para 40, “complete
consistency of approach” between different national courts of the EPC states “is not
a feasible or realistic possibility at the moment”, but nonetheless “it is sensible for
national courts at least to learn from each other and to seek to move towards, rather
than away from, each other’s approaches”.
33. More specifically, two points appear to be clear from the Protocol. The first,
which can be deduced from article 1, is that the scope of protection afforded to a
patentee is not to be limited by the literal meaning of the claims. However, it is not
at all clear how far a court is permitted to move away from the literal meaning. I do
not consider that the last part of the first sentence of article 1 only enables the
description (ie the specification) and the drawings to be taken into account when
interpreting the claims, in cases where the claims would otherwise be ambiguous.
Any doubt about this must be put to rest by the second and third sentences, which
make it clear to my mind that that would be too narrow a reading. However, it is
very hard to be confident how far they were intended to permit a court to go beyond
the actual language of a claim when interpreting a claim. Secondly, it is apparent
from article 2 that there is at least potentially a difference between interpreting a
claim and the extent of the protection afforded by a claim, and, when considering
the extent of such protection, equivalents must be taken into account, but no
guidance is given as to precisely what constitutes an equivalent or how equivalents
are to be taken into account.
34. The question of how far one can go outside the wording of a claim to enable
the patentee to enjoy protection against products or processes which are not within
the ambit of the actual language, construed in accordance with ordinary principles
of interpretation, has been considered in three significant UK cases and in a number
of significant cases decided in the courts of other Convention states.
The domestic case law
35. The UK case of Catnic Components Ltd v Hill & Smith Ltd [1982] RPC 183
was decided under the previous, purely domestic, legislation, the Patents Act 1949.
At pp 242 to 243, Lord Diplock deprecated the notion that there were two types of
infringement, “textual infringement” and “infringement of the ‘pith and marrow’ of
the invention”, and said that there was “a single cause of action”, which involved
asking the question:
Page 13
“whether persons with practical knowledge and experience of
the kind of work in which the invention was intended to be
used, would understand that strict compliance with a particular
descriptive word or phrase appearing in a claim was intended
by the patentee to be an essential requirement of the invention
so that any variant would fall outside the monopoly claimed,
even though it could have no material effect upon the way the
invention worked.”
He continued:
“The question, of course, does not arise where the variant
would in fact have a material effect upon the way the invention
worked. Nor does it arise unless at the date of publication of
the specification it would be obvious to the informed reader
that this was so. Where it is not obvious, in the light of thenexisting knowledge, the reader is entitled to assume that the
patentee thought at the time of the specification that he had
good reason for limiting his monopoly so strictly and had
intended to do so, even though subsequent work by him or
others in the field of the invention might show the limitation to
have been unnecessary. It is to be answered in the negative only
when it would be apparent to any reader skilled in the art that a
particular descriptive word or phrase used in a claim cannot
have been intended by a patentee, who was also skilled in the
art, to exclude minor variants which, to the knowledge of both
him and the readers to whom the patent was addressed, could
have no material effect upon the way in which the invention
worked.”
36. In that case, the patent was for a novel type of galvanised steel lintel, which
the relevant claim described as including a rear support back plate “extending
vertically” from a horizontal plate. The allegedly infringing article included a rear
support member which was inclined between 6 degrees and 8 degrees from the
vertical. Overruling the Court of Appeal’s decision that this meant that there was no
infringement, Lord Diplock said at p 244, that it would have been:
“obvious to a builder familiar with ordinary building operations
that the description of a lintel in the form of a weight-bearing
box girder of which the back plate was referred to as ‘extending
vertically’ from one of the two horizontal plates to join the
other, could not have been intended to exclude lintels in which
the back plate although not positioned at precisely 90 degree to
Page 14
both horizontal plates was close enough to 90 degree to make
no material difference to the way the lintel worked when used
in building operations.”
He then added this:
“No plausible reason has been advanced why any rational
patentee should want to place so narrow a limitation on his
invention. On the contrary, to do so would render his monopoly
for practical purposes worthless, since any imitator could avoid
it and take all the benefit of the invention by the simple
expedient of positioning the back plate a degree or two from
the exact vertical.”
37. A few years later, Hoffmann J (as he then was) gave judgment in Improver
Corpn v Remington Consumer Products Ltd [1990] FSR 181. The case concerned a
patent for a depilator, known as the “Epilady”, which worked by trapping hairs in a
rotating “coiled helical spring”, and the alleged infringement worked in very much
the same way save that, instead of a spring, it used a slotted rubber rod. The case
had already gone on an interlocutory issue to the Court of Appeal, where it was held
that Lord Diplock’s approach in Catnic [1982] RPC 183 was consistent with the
1977 Act, the EPC 1973 and the Protocol as it then was – see [1989] RPC 69.
38. At [1990] FSR 181, 189, Hoffmann J suggested the following approach,
largely based on his reading of the reasoning in Catnic [1982] RPC 183, 242 to 243:
“If the issue was whether a feature embodied in an alleged
infringement which fell outside the primary, literal or a
contextual meaning of a descriptive word or phrase in the claim
(‘a variant’) was nevertheless within its language as properly
interpreted, the court should ask itself the following three
questions:
(1) Does the variant have a material effect upon the
way the invention works? If yes, the variant is outside
the claim. If no –
(2) Would this (ie that the variant had no material
effect) have been obvious at the date of publication of
the patent to a reader skilled in the art? If no, the variant
is outside the claim. If yes –
Page 15
(3) Would the reader skilled in the art nevertheless
have understood from the language of the claim that the
patentee intended that strict compliance with the
primary meaning was an essential requirement of the
invention? If yes, the variant is outside the claim.
On the other hand, a negative answer to the last question would
lead to the conclusion that the patentee was intending the word
or phrase to have not a literal, but a figurative meaning (the
figure being a form of synecdoche or metonymy) denoting a
class of things which included the variant and the literal
meaning, the latter being perhaps the most perfect, best-known
or striking example of the class.”
39. Hoffmann J then proceeded to apply those three questions to the facts of the
case before him. He held that the first two questions were to be answered in the
patentee’s favour and then turned to the third question. On that question, he held that
the patentee failed for the reasons he gave at p 197, namely that “[t]he rubber rod is
not an approximation to a helical spring”, that “the spring [cannot] be regarded as
an ‘inessential’ or the change from metal spring to rubber rod as a minor variant”,
and that it could be appreciated that the patentee would wish to restrict his claim to
helical springs as “[i]t would be obvious that the rubber had problems of hysteresis
which might be very difficult to overcome”.
40. Thereafter, for the next 15 years or so, this three-stage approach was almost
routinely applied by judges in UK patent infringement cases, where the three
“Improver questions” were subsequently renamed the three “Protocol questions” –
see Wheatley v Drillsafe Ltd [2001] RPC 7, para 23.
41. Lord Hoffmann (as he had by then become) addressed the issue again in his
speech in Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2005] RPC 9, where one
of the issues was whether a protein manufactured by gene-activation infringed a
patent relating to production of the same protein by recombinant DNA technology.
At paras 27 to 35, Lord Hoffmann discussed “the English rules of construction”. At
paras 30 to 32 he effectively equated Lord Diplock’s approach to patents in Catnic
[1982] RPC 183, 243 with “purposive construction” of commercial contracts. At
para 34, he said that “[t]he question is always what the person skilled in the art would
have understood the patentee to be using the language of the claim to mean. And for
this purpose, the language he has chosen is usually of critical importance”.
42. Lord Hoffmann then turned to the doctrine of equivalents, which he
explained in para 37 had been developed in the United States courts and “allow[ed]
Page 16
the patentee to extend his monopoly beyond his claims”, so as to prevent “the
unscrupulous copyist [from making] unimportant and insubstantial changes and
substitutions in the patent which, though adding nothing, would be enough to take
the copied matter outside the claim, and hence outside the reach of law”, quoting
Jackson J in Graver Tank & Manufacturing Co Inc v Linde Air Products Co 339 US
605, 607 (1950). Lord Hoffmann expressed concern that “once the monopoly had
been allowed to escape from the terms of the claims, it is not easy to know where its
limits should be drawn”, and concluded that, rather than adhering to literalism and
adopting the doctrine, the solution was “to adopt a principle of construction which
actually gave effect to what the person skilled in the art would have understood the
patentee to be claiming”, as Lord Diplock had done in Catnic [1982] RPC 183. He
also said that article 69 EPC 2000 “firmly shuts the door on any doctrine which
extends protection outside the claims” (see at paras 39 and 42 to 44).
43. Having considered the issue in the three preceding paragraphs of his speech,
at para 48 Lord Hoffmann stated that the approach adopted by Lord Diplock was
“precisely in accordance with the Protocol”, as it was “intended to give the patentee
the full extent, but no more than the full extent, of the monopoly which a reasonable
person skilled in the art, reading the claims in context, would think he was intending
to claim”. He concluded his discussion by quoting with approval the passages quoted
above from Catnic [1983] RPC 183, 243 and Improver [1990] FSR 181, 189, and
saying in para 52 that the principle of purposive construction as Lord Diplock and
he had explained it, gave “effect to the requirements of the Protocol” and was “the
bedrock of patent construction, universally applicable”, whereas the Protocol or
Improver questions were simply “guidelines for applying that principle to
equivalents … , more useful in some cases than in others”.
The approach in the courts of other EPC states
44. In Germany, the Bundesgerichtshof has stated that a variant will infringe if
(i) “it solves the problem underlying the invention with modified but objectively
equivalent means”, (ii) this would be recognised by the person skilled in the relevant
art, and (iii) that person “focus[sing] on the essential meaning of the technical
teaching protected in the patent” would regard the variant “as being equivalent to
the solution” offered by the invention – see Case No X ZR 168/00, 2002 GRUR 519
(Schneidmesser I), para 30. (It is worth noting that in paras 36 to 38 of its judgment
in that case, the Bundesgerichtshof expressly considered the approach which had
been adopted in Catnic [1982] RPC 183 and Improver [1990] FSR 181.) Judge
Meier-Beck of the Bundesgerichtshof, writing extra-judicially (The Scope of Patent
Protection – The Test for Determining Equivalence (2005) 36 IIC 339, 342 to 343)
has suggested that the second step involves asking whether “the person skilled in
the art, using his specialist knowledge, [would be] able to find the modified means
at the priority date as having the same effect”, which he then says has the “meaning
that no inventive step is needed”. That seems to be supported by what was said by
Page 17
the Bundesgerichtshof in Case No X ZR 156/97, 1999 GRUR 977, (Räumschild),
paras II.2(c)(aa) and III.1.
45. Further guidance as to the German approach to equivalents was very recently
given by the Munich Oberlandesgericht, upholding the decision of the Landgericht,
in Case No 6 U 3039/16 (Eli Lilly & Co v ratiopharm GmbH), when considering
whether pemetrexed ditromethamine infringed the German equivalent of the Patent
in this case. At para II.B.3(a), the Oberlandesgericht said that in order for “an
embodiment that deviates from the literal meaning of the claim” to be within the
scope of protection, “generally three requirements must be met”. The first was that
“the embodiment must solve the problem underlying the invention with means that
are indeed modified, but are objectively equivalent”. The second requirement was
that “the expertise of the person skilled in the art must enable him to discover the
modified embodiment with its divergent means to be equivalent”. Thirdly, “the
thought processes that the person skilled in the art has to perform in order to do so
must be oriented on the meaning of the teaching protected in the claim”. In para
II.B.3(b)(aa), the Oberlandesgericht suggested that “the decisive factor” was “what
individual effects the features according to the patent … provide in order to attain
the object underlying the claims and whether these effects are achieved through
other means by the [allegedly infringing] embodiment”. The court added that the
doctrine of equivalence would apply to an embodiment “if it not only essentially
achieves the entire effect of the invention, but specifically also achieves the effect
that the feature, which has not been literally implemented, is supposed to achieve”.
46. French law, according to the expert witnesses in this case, applies the doctrine
of equivalents where the variant is “different in form but perform[s] the same
function” as the invention, but only where “the function [claimed in the patent] is a
new one”. This seems to be supported by Azéma and Galloux, Droit de la propriété
industrielle, 7th ed (2012), which distinguishes at p 442 between two categories of
patents. The first category is those which “in general terms claim the means that
provide for a particular function” (moyens généraux), or as Arnold J put it in para
160 of his judgment, claims which cover “general means”. The second category is
patents “which indicate the particular means which infer such function” (moyens
particuliers), or claims which are “narrowly worded to cover specific means” as
Arnold J expressed it. The doctrine is only normally applicable to the first category
of claims. Arnold J added in para 160 that the categorisation of a patent for this
purpose may depend in part on what was known at the priority date – see the
decisions of the Cour de Cassation in Appeal S 09-15668 Institut Pasteur v Chiron
Healthcare, 23 November 2010 and of the Paris Tribunal de Grande Instance in Case
09/01863 Mundipharma Laboratories GmbH v Sandoz SAS, 2 July 2010.
47. As Arnold J also explained in para 159 of his judgment, “there is no need for
the claim to be unclear or for it to be widely worded” for the doctrine of equivalents
to be invoked in the French court. Thus, in the decision of the Cour de Cassation in
Page 18
Appeal No 06-17915 B2M Industries v Acome, 20 November 2007, “the function of
the particular integer that was said to be infringed pursuant to an equivalent was held
to be novel, and therefore because the means that was said to be equivalent to that
integer performed the same function and produced the result sought by the invention
the means was equivalent to that integer”, to quote from para 161 of Arnold J’s
judgment.
48. In the Italian courts, the expert witnesses in this case agreed that a variant
would be held to infringe if (i) it reproduced the “inventive core” of the patent and
(ii) it was an obvious variation, although (iii) the fact that the variant included some
modifications which were not obvious and/or the fact that the variant does not
include some of the elements of the patent claim does not necessarily prevent the
variant infringing – see per Arnold J at para 171 of his judgment. This analysis is
supported by the Corte di Cassazione decisions in Case No 257, Forel SpA v Lisec
(13 January 2004), Case No 30234, Barilla GER Fratelli SpA v Pastifico Fazion
SpA (30 December 2012) and Case No 622, Entsorga Italia Srl v Ecodeco Srl (11
January 2013).
49. At any rate at local appellate level, Spanish courts appear to have effectively
adopted the approach embodied in the three questions suggested by Hoffmann J in
Improver [1990] FSR 181 – see for instance Laboratorios Cinfa SA v Eli Lilly & Co
Ltd (“Olanzapine”) Court of Appeal of Barcelona judgment no 8/2008, 17 January
2008.
50. Following circulation of this judgment in draft, Actavis referred us to a
decision of the Spanish Tribunal Supremo Lundbeck v Cinfa, no 223/2015, 29 April
2015. In the closely reasoned section ELEVEN of its judgment, the Tribunal
Supremo (i) recorded the fact that none of the parties challenged the approach of the
Court below which applied the three Improver questions (para 5), (ii) stated that the
real issue in the case centred on the second question (para 6), (iii) cast some doubt
on the applicability of the Improver questions in Spanish law (para 10), (iv)
disapproved the notion that the test for obviousness in patentability is necessarily
applicable to the second Improver question (paras 10 and 14), (v) disapproved the
notion that, for the second Improver question to be answered yes, “the skilled person
must be absolutely certain that the variant … would work successfully in resolving
the technical problem faced by the patented invention” (paras 11 and 12), (vi)
preferred instead, a test of “easy to see or comprehend” and “a degree of
predictability” (paras 11 and 18), which involves “a high probability”, rather than a
“reasonable expectation” that the variant would work (paras 15 and 18), and (vii)
concluded on this basis that the Court of Appeal was right to rule that the allegedly
infringing products in that case did not infringe (paras 18 and 19).
Page 19
51. As for the Netherlands, helpful guidance may be found in a lecture given in
2016 by Judge Kalden, the head of the IP division in the Court of Appeal in The
Hague – Article 69 EPC – the Scylla and Charybdis of the European Patent
Convention – Which route did the Dutch courts take? (2016 Symposium German
Bundespatentgericht). She said that, although there have been subtle changes of
emphasis in its decisions, the Supreme Court tends to focus on “the inventive
concept in order to prevent a too literal interpretation of the claims, which could do
injustice to fair protection for the patentee (or lead to an unnecessary broad
interpretation)”. She also explained that the doctrine of equivalents applies if (i) the
variant is “foreseeable at the priority date”, (ii) “the inventive concept is sufficiently
broad to … cover [the] variant”, (iii) “the variant makes use of – and thus benefits
from – the inventive concept”, and (iv) “reasonable legal certainty [is not thereby]
unduly compromised”. She added that, despite the first condition:
“Variants that are not foreseeable at the priority date may well,
due to later developments, become an obvious variant at a later
date. This may happen in case of a pioneer invention, where at
the priority date the full breadth of the possible applications
could or has not been fully recognised and therefore was not
sufficiently taken into account when drafting a claim. Another
possibility is that a new technique becomes available after the
patent was granted, which makes available an obvious variant.
It would be harsh and contrary to fair protection for the patentee
to deny him the right to attack those, again provided such
variant falls within the inventive concept and reasonable legal
certainty is taken into account. So infringement by equivalence
is not limited to foreseeable variants only.”
52. It may be of some significance that the product which Hoffmann J concluded
in Improver [1990] FSR 181 was non-infringing was held by the German, Italian
and Dutch courts to infringe. Of course, the fact that courts of two states reach
different conclusions on the same issue does not of itself mean that there is a
difference in the law of those states, let alone that one court is wrong and the other
right: the evidence may be different, and there may be issues of judgment on which
reasonable judges could differ. However, consideration of the judgments in those
three other courts does suggest a difference of approach. Thus, in Germany, the
Düsseldorf Oberlandesgericht based its conclusion on the propositions that “a
person skilled in the art will not interpret the coil spring as a spring, but as an elastic
body with gaps … as it is obvious that the helical spring is not used as a spring per
se”, and that its only essential function, which was shared by the allegedly infringing
product’s slitted rubber rod, was that it could “enter between adjacent areas of the
body (walls), and that the walls must approach it up to clamping it” – see Epilady
Germany II (1993) 24 IIC 838. In Italy, the Milan District Court held that there was
infringement because the slitted rubber rod had structural characteristics which
Page 20
enabled it to perform the same function in the same way as the coiled spring referred
to in the patent in suit – see Epilady Italy (1992) Giur Ann Dir Ind, Case No 2823.
In the Netherlands, the Gerechtshof upheld the first instance decision that the
allegedly infringing “device embodies an application of the patented invention, on
the grounds that the hair-engaging component [ie the slitted rubber rod] of the device
is a mechanical equivalent of the helical spring specified in the patent claims”, and
the rod was “not state of the art in the field of depilatory devices” – Epilady
Netherlands III (1993) 24 IIC 832, paras 9 and 11.
The proper approach to infringement claims
53. Any patent system must strike a balance between the two competing factors
referred to at the end of article 1 of the Protocol, namely “a fair protection for the
patent proprietor [and] a reasonable degree of legal certainty for third parties”. The
balance cannot be struck on an ad hoc case-by-case basis without any guiding
principles, as that would mean that there was no legal certainty. On the other hand,
striking the balance by adopting a normal approach to interpretation would risk
depriving patentees of a proper measure of protection; as explained in paras 37 to
39 and 52 above, that is clear from the approach of all the courts which considered
the “Epilady” patent, where it could not seriously have been suggested that, as a
matter of language, a slotted rubber rod falls within the expression “helical metal
spring”, even if one was construing those words in the context of the claim in the
patent in suit. But, if one departs from ordinary language, it is necessary to have
some guidance or to draw some lines, as Lord Hoffmann implied in Kirin-Amgen
[2005] RPC 9, para 37. That is why he promulgated his three questions in Improver
[1990] FSR 181, 189. By means of an extended version of the ordinary concept of
“construction” or “interpretation”, Hoffmann J explained how our domestic law, as
laid down in Catnic [1982] RPC 183, implements article 2 of the Protocol and thus,
as I see it, how it gives effect to the doctrine of equivalents. That approach was
(perhaps unsurprisingly) then adopted in Kirin-Amgen [2005] RPC 9.
54. In my view, notwithstanding what Lord Diplock said in Catnic [1982] RPC
183, 242, a problem of infringement is best approached by addressing two issues,
each of which is to be considered through the eyes of the notional addressee of the
patent in suit, ie the person skilled in the relevant art. Those issues are: (i) does the
variant infringe any of the claims as a matter of normal interpretation; and, if not,
(ii) does the variant nonetheless infringe because it varies from the invention in a
way or ways which is or are immaterial? If the answer to either issue is “yes”, there
is an infringement; otherwise, there is not. Such an approach complies with article
2 of the Protocol, as issue (ii) squarely raises the principle of equivalents, but limits
its ambit to those variants which contain immaterial variations from the invention.
It is also apparent that the two issues comply with article 1 of the Protocol in that
they involve balancing the competing interests of the patentee and of clarity, just as
much as they seek to balance the encouragement of inventions and their disclosure
Page 21
with the need for a competitive market. In my view, issue (i) self-evidently raises a
question of interpretation, whereas issue (ii) raises a question which would normally
have to be answered by reference to the facts and expert evidence.
55. In Kirin-Amgen [2005] RPC 9, Lord Hoffmann, following his approach in
Improver [1990] FSR 181 (which itself had followed Lord Diplock’s analysis in
Catnic [1982] RPC 183) effectively conflated the two issues, and indicated that the
conflated issue involved a question of interpretation. I have considerable difficulties
with the notion that there is a single conflated, or compound, issue, and, even if that
notion is correct, that that issue raises a question of interpretation. Indeed, in my
view, to characterise the issue as a single question of interpretation is wrong in
principle, and unsurprisingly, therefore, can lead to error. While normal principles
of interpretation could, I think, accommodate the notion that “vertically” extended
to an item which was not at precisely 90° to another item, I do not see how such
principles could possibly lead to the conclusion that a slotted rubber rod was within
the expression “helical metal spring”. As Hoffmann J said in Improver [1990] FSR
181, 197, “the angle of the support member [in the allegedly infringing product in
Catnic [1982] RPC 183] can be regarded as an approximation to the vertical”, but
“[t]he rubber rod is not an approximation to a helical spring”. The problem with
treating the issue as one of normal interpretation is thus that that point alone may be
thought to have been sufficient to put an end to the patentee’s infringement argument
on facts such as those in Improver [1990] FSR 181, and there would seem to have
been little purpose in going through the three questions in that case.
56. I had wondered whether the question whether issue (ii) truly involves a
question of interpretation raised what was merely an arid issue of categorisation.
However, I have concluded that that nettle needs to be grasped, because, so long as
the issue is treated as one of interpretation, it will lead to a risk of wrong results in
patent infringement cases and it will also lead to a risk of confusing the law relating
to the interpretation of documents. In my opinion, issue (ii) involves not merely
identifying what the words of a claim would mean in their context to the notional
addressee, but also considering the extent if any to which the scope of protection
afforded by the claim should extend beyond that meaning. As Sir Hugh Laddie wrote
in his instructive article Kirin-Amgen – The End of Equivalents in England? (2009)
40 IIC 3, para 68, “[t]he Protocol is not concerned with the rules of construction of
claims” but with “determining the scope of protection”.
57. I might add that the notion of a product or process which infringes despite an
immaterial variation from the invention as claimed is by no means new to domestic
patent law. That point is convincingly demonstrated by Sir Hugh in his article at
paras 33 to 39. Thus, in Walton v Potter & Horsfall (1843) 1 WPC 585, Tindal CJ
told the jury that they had to decide whether the defendant’s product was “perfectly
distinct” from the patented product, or whether it varied “only in certain
circumstances, which are not material to the principle and substance of the
Page 22
invention”. And Lord Cairns LC in Clark v Adie (1877) 2 App Cas 315, 320, referred
to the alleged infringer having “really taken and adopted the substance of the
instrument patented”, and having “taken in substance the pith and marrow of the
invention”. The patents in these cases included relatively primitive forms of claim,
but that does not undermine the fact that our domestic law has long recognised that
an immaterial variation does not get an infringer off the hook. Particularly in the
light of what he said in Catnic [1983] RPC 183, 242, it is worth mentioning that
Lord Diplock himself in Beecham Group Ltd v Bristol Laboratories Ltd [1978] RPC
153, 200 rejected a submission that “[t]he increasing particularity with which claims
are drafted … has made the doctrine [of pith and marrow] obsolete”, and said that
the doctrine “still remains a part of patent law”.
58. Turning to the two issues identified in para 54 above, issue (i), as already
mentioned, involves solving a problem of interpretation, which is familiar to all
lawyers concerned with construing documents. While the answer in a particular case
is by no means always easy to work out, the applicable principles are tolerably clear,
and were recently affirmed by Lord Hodge in Wood v Capita Insurance Services Ltd
[2017] 2 WLR 1095, paras 8 to 15. In the present case, there is no doubt that,
according to normal principles of interpreting documents, the Actavis products do
not infringe the Patent, as in no sensible way can pemetrexed free acid, pemetrexed
ditromethamine, or pemetrexed dipotassium mean, ie be said to fall within the
expression, “pemetrexed disodium” in claim 1 of the Patent, any more than a slotted
rubber rod can be said to be within the expression “a helical metal spring” in the
claim in the Improver patent. According to normal principles of interpreting
documents, then, this would be the end of the matter.
59. However, the second issue poses more difficulties of principle: what is it that
makes a variation “immaterial”? In that connection, I consider that Hoffmann J’s
three questions in Improver [1990] FSR 181 provide helpful assistance, a view
supported by the fact explained in paras 44 to 52 above that similar but not identical
tests have been adopted in other EPC jurisdictions. However, each of the three
questions requires some exegesis, and, particularly the second question, some
reformulation.
60. The first Improver question, which asks whether the variant has a material
effect on the way in which the invention works, seems generally satisfactory. It is a
question which was framed in the context of a mechanical patent, and is not wholly
aptly expressed for every type of case. However, in practice, the question as framed
by Hoffmann J, with its emphasis on how “the invention” works, should correctly
involve the court focussing on the “the problem underlying the invention”, “the
inventive core”, or “the inventive concept” as it has been variously termed in other
jurisdictions. In effect, the question is whether the variant achieves the same result
in substantially the same way as the invention. If the answer to that question is no,
then it would plainly be inappropriate to conclude that it could infringe. If, by
Page 23
contrast, the answer is yes, then it provides a sound initial basis for concluding that
the variant may infringe, but the answer should not be the end of the matter.
61. The second Improver question is more problematic. In my view, it imposes
too high a burden on the patentee to ask whether it would have been obvious to the
notional addressee that the variant would have no material effect on the way in
which the invention works, given that it requires the addressee to figure out for
himself whether the variant would work. The facts of the present case serve to make
that proposition good. As Floyd LJ explained in para 65 of his judgment below,
because a chemist “would not be able to predict the effect of [a] substitution [for the
sodium counter-ion] without testing at least the solubility of the [active ingredient
in the Actavis products]”, it followed that “predicting in advance whether any
particular counter-ion would work was not possible”, and therefore that the second
Improver test could not be answered yes. However, as mentioned in para 25(i)
above, salt screening is a routine exercise in determining suitability, and as Floyd
LJ said, “the chemist would be reasonably confident that he would come up with a
substitute for the sodium counter-ion”. In those circumstances, given that the
inventive concept of the patent is the manufacture of a medicament which enables
the pemetrexed anion to be administered with vitamin B12, it appears to me that
application of the second Improver question fails to accord “a fair protection for the
patent proprietor” as required by article 1 of the Protocol.
62. In my opinion, the second question is better expressed as asking whether, on
being told what the variant does, the notional addressee would consider it obvious
that it achieved substantially the same result in substantially the same way as the
invention. In other words, it seems to me that the second Improver question should
be asked on the assumption that the notional addressee knows that the variant works
to the extent that it actually does work. That, I think, would be a fair basis on which
to proceed in terms of balancing the factors identified in article 1 of the Protocol,
and it is, I think, consistent with the approach of the German, Italian and Dutch
courts. It is also consistent with the fact that the notional addressee is told (in the
patent itself) what the invention does.
63. This reformulated second question should also apply to variants which rely
on, or are based on, developments which have occurred since the priority date, even
though the notional addressee is treated as considering the second question as at the
priority date. Such an approach is supported by the desirability of both consistency
of approach and pragmatic justice. It seems right in principle to have the same
question, including the same assumption (ie that the variant works) for all cases. As
to pragmatism, the point is touched on by Judge Kalden in the passage quoted at the
end of para 51 above: while the notional addressee may answer the reformulated
second question affirmatively even where the variant was unforeseeable at the
priority date, he is less likely to do so than in relation to a variant which was
unforeseeable as at that date.
Page 24
64. The second test applied by the German courts, as I understand it, at least
sometimes appears to require the variation not to be inventive, but I am not sure that
that is an appropriate requirement, although it is unnecessary to decide that point on
this appeal. If the variation represents an inventive step, while it may render it less
likely that the patentee will succeed on the second reformulated question, I find it
hard to see why that alone should prevent the resultant variant from infringing the
original invention. It may entitle the infringer to a new patent, in the same way as
the invention of a novel use for a patented invention can itself be patented, but like
such a novel use I see no reason why the variant should not infringe the original
patent. Having said that, it should be added that the German version of the second
test will, I suspect, usually produce the same result as the reformulated second
question.
65. The third Improver question as expressed by Hoffmann J is whether the
notional addressee would have understood from the language of the claim that the
patentee intended that strict compliance with the primary meaning was an essential
requirement of the invention. That is in my view an acceptable test, provided that it
is properly applied. In that connection, I would make four points. First, although
“the language of the claim” is important, consideration of the third question certainly
does not exclude the specification of the patent and all the knowledge and expertise
which the notional addressee is assumed to have. Secondly, the fact that the language
of the claim does not on any sensible reading cover the variant is certainly not
enough to justify holding that the patentee does not satisfy the third question. Hence,
the fact that the rubber rod in Improver [1990] FSR 181 could not possibly be said
to be “an approximation to a helical spring” (to quote from p 197) was not the end
of the infringement issue even in Hoffmann J’s view: indeed, as I have already
pointed out, it was because the rubber rod could not possibly be said to be a helical
spring that the allegedly infringing product was a variant and the patentee needed to
invoke the three Improver questions. Thirdly, when considering the third question,
it is appropriate to ask whether the component at issue is an “essential” part of the
invention, but that is not the same thing as asking if it is an “essential” part of the
overall product or process of which the inventive concept is part. So, in Improver
[1990] FSR 181, 197, Hoffmann J may have been (and I mean “may have been”)
wrong to reject the notion that “the spring could be regarded as an ‘inessential’”:
while it was undoubtedly essential to the functioning of the “Epilady”, the correct
question was whether the spring would have been regarded by the addressee as
essential to the inventive concept, or inventive core, of the patent in suit. Fourthly,
when one is considering a variant which would have been obvious at the date of
infringement rather than at the priority date, it is, as explained in para 63 above,
necessary to imbue the notional addressee with rather more information than he
might have had at the priority date.
66. In these circumstances, given the weight that has been given by courts in this
jurisdiction (and indeed in some other jurisdictions) to the three “Improver
Page 25
questions”, I think it must be right for this court to express in our own words our
reformulated version of those questions. In doing so, it is right to emphasise, as Lord
Hoffmann did in Kirin-Amgen [2005] RPC 9, para 52, that these questions are
guidelines, not strict rules (as indeed the Oberlandesgericht indicated in Case No 6
U 3039/16, when saying that it was “generally” true that “three requirements must
be met”). While the language of some or all of the questions may sometimes have
to be adapted to apply more aptly to the specific facts of a particular case, the three
reformulated questions are as follows:
i) Notwithstanding that it is not within the literal meaning of the relevant
claim(s) of the patent, does the variant achieve substantially the same result
in substantially the same way as the invention, ie the inventive concept
revealed by the patent?
ii) Would it be obvious to the person skilled in the art, reading the patent
at the priority date, but knowing that the variant achieves substantially the
same result as the invention, that it does so in substantially the same way as
the invention?
iii) Would such a reader of the patent have concluded that the patentee
nonetheless intended that strict compliance with the literal meaning of the
relevant claim(s) of the patent was an essential requirement of the invention?
In order to establish infringement in a case where there is no literal infringement, a
patentee would have to establish that the answer to the first two questions was “yes”
and that the answer to the third question was “no”.
Provisional conclusion on direct infringement in the UK
67. Given that the Actavis products do not infringe on the basis of a normal
interpretation of claim 1 of the Patent, it is necessary to consider whether they
represent an immaterial variation on that claim. I propose to address that issue
initially disregarding the prosecution history, and having reached a provisional
conclusion, I will then address that history and its effect on the provisional
conclusion.
68. In my view, application in the present case of the three questions just
identified results in the conclusion that the Actavis products infringe. So far as the
first question is concerned, there can be no doubt but that those products work in the
same way as the invention: they all ultimately involve a medicament containing the
pemetrexed anion and vitamin B12. Thus, they achieve substantially the same result
Page 26
in substantially the same way as the invention. Indeed, as in the Court of Appeal,
Actavis realistically accept that the first question is to be answered yes.
69. As to the second question, it seems to me clear that the notional addressee of
the Patent would appreciate (and would have appreciated as at the priority date) that
each of the Actavis products would work in precisely the same way as pemetrexed
disodium when included in a medicament with vitamin B12. When it comes to
different versions of pemetrexed medicaments, it is clear that the use of a free acid,
and of ditromethamine and dipotassium salts was in each case well established as at
the priority date – see para 26(ii) to (iv) above. Furthermore, the notional addressee
of the Patent would regard investigating whether pemetrexed free acid, pemetrexed
ditromethamine or pemetrexed dipotassium worked as a purely routine exercise –
see para 25(i) above. The reason why I differ from the Court of Appeal and Arnold
J on this second question is that, in accordance with the second question as
formulated in Improver [1990] FSR 181, 189, they considered that the notional
addressee should not be treated as knowing that the Actavis products did in fact
work at all, whereas, as explained above, that seems to me to involve too strict a
test.
70. Turning to the third question, the Court of Appeal considered that the notional
addressee “would understand that the patent was clearly limited to the disodium salt,
and did not extend to the diacid, or the dipotassium or ditromethamine salts”. They
based this conclusion on the fact that the specification of the Patent contains a
number of passages (eg in Para [0022] of the specification, quoted in para 19 above)
which refer to “anti-folates” and the like and other passages which refer to
pemetrexed disodium, which is “a highly specific chemical compound”, and the fact
that the claim is limited to pemetrexed disodium would therefore lead the notional
addressee to conclude that the claim is indeed intended to be so limited (see paras
71 and 72 of Floyd LJ’s judgment).
71. In my opinion, the Court of Appeal adopted an approach which places too
much weight on the words of the claim and not enough weight on article 2 of the
Protocol (and it is only right to add that, in doing so, they were, like Arnold J at first
instance, following Lord Hoffmann’s guidance in Kirin-Amgen [2005] RPC 9).
Thus, when considering the third test, Floyd LJ made the point at para 72(ii) of his
judgment that “there is no obvious leeway as a matter of language for giving it a
broad as opposed to a narrow construction”. That seems to me to demonstrate the
risk of treating the issue raised by the third question as being one of normal
interpretation. (Another way of looking at the point is, in the language of Sir Hugh
Laddie, that it involves wrongly conflating the issue of interpretation with the issue
of scope of protection.) As already explained, if it was a decisive point it would
make a nonsense of asking the three questions: if one cannot depart from the
language of the claim when considering those questions, what is the point of the
questions in the first place?
Page 27
72. More specifically, I do not agree with the Court of Appeal’s view that,
because the specification referred to “anti-folates” and “anti-folate drugs”, the fact
that the claims were limited to pemetrexed disodium means that the drafter of the
Patent would have been understood to intend that the other pemetrexed compounds
would not infringe. As Mr Mitcheson QC contended in his well argued case, the
point is neutral because there is no reference to pemetrexed salts as a class in the
specification, and the contrast therefore does not help on the question whether
pemetrexed salts other than pemetrexed disodium were intended to be excluded.
73. Further, contrary to the Court of Appeal’s reasoning, I would have thought
that if the specification had not referred to anti-folates but had only referred to
pemetrexed disodium, that would have been a more powerful indication that the
patentee was intending to limit himself to pemetrexed disodium. The very fact that
the specification teaches that there are other anti-folate drugs which have a similar
effect to pemetrexed disodium (coupled with the fact that it was generally known
that cations other than sodium could be successfully used with anti-folates)
highlights a point similar to that made by Lord Diplock in Catnic [1982] RPC 183,
244, namely “No plausible reason has been advanced why any rational patentee
should want to place so narrow a limitation on his invention” as to limit the scope
of protection afforded by the Patent to pemetrexed disodium – a telling but not
always conclusive point. Additionally, there is no teaching in the specification
which relates to the relevance or importance of the sodium cation.
74. Looking at matters more broadly, the addressee of the Patent would, as I see
it, understand that the reason why the claims were limited to the disodium salt was
because that was the only pemetrexed salt on which the experiments described in
the specification had been carried out. However, it does not follow that the patentee
did not intend any other pemetrexed salts to infringe: the suggestion confuses the
disclosure of the specification of a patent with the scope of protection afforded by
its claims. Particularly given the facts set out in para 25 above, it seems to me very
unlikely that the notional addressee would have concluded that the patentee could
have intended to exclude any pemetrexed salts other than pemetrexed disodium, or
indeed pemetrexed free acid, from the scope of protection.
75. Accordingly, I would conclude that, subject to considering the prosecution
history, the Actavis products infringe claim 1 of the Patent.
The effect of the prosecution history
76. The application for the patent was filed at the EPO in June 2001, and it
contained claims directed to a method of treatment, claims in Swiss form, and
purpose-related product claims. In January 2003, Dr Burnside, Lilly’s patent
Page 28
attorney, filed a revised set of claims which omitted the method of treatment claims.
Claims 1 and 2 were as follows:
“1. Use of a methylmalonic acid lowering agent in the
preparation of a medicament useful in lowering the mammalian
toxicity associated with an antifolate, and the medicament is
administered in combination with an antifolate.
2. Use of a methylmalonic acid lowering agent in the
preparation of a medicament useful in lowering the mammalian
toxicity associated with an antifolate, and the medicament is
administered in combination with an antifolate and a FBP
binding agent.”
Claim 10 was a dependent claim “wherein the antifolate is ALIMTA”.
77. As Floyd LJ said, these claims are in the reverse order from the claims
ultimately granted (as they start with the use of the methylmalonic lowering agent
rather than pemetrexed disodium), but nothing hangs on that. The essential point is
that these claims were entirely general as to the identity of the antifolate. In March
2004, the EPO examiner wrote raising various objections including some under
articles 83 and 84 EPC 2000 (disclosure and clarity). The clarity and lack of
disclosure objections were that the claims related to too many possible combinations
of compounds by using general expressions such as “antifolate”, “methylmalonic
acid lowering agent” and “FBP binding agent”. Moreover, the examiner was
concerned that the claims covered all compounds having these characteristics or
properties, whereas the application provided support and disclosure for only a very
limited number of such compounds.
78. Dr Burnside replied in a letter of December 2004, under cover of which he
filed new claims 1 and 2, this time starting with the use of the antifolate, now limited
to “pemetrexed” in these terms:
“1. Use of pemetrexed in the manufacture of a medicament
for use in combination therapy for inhibiting tumour growth in
mammals wherein said medicament is to be administered in
combination with vitamin B12 or a pharmaceutical derivative
thereof.
2. Use according to claim 1 wherein said medicament is to
be administered in combination with vitamin B12 or a
Page 29
pharmaceutical derivative thereof and a folic binding protein
binding agent [which was then defined].”
In support of these new claims, Dr Burnside said that, “in order to expedite the
application proceeding to grant”, Lilly had elected to amend the claims so as to
reflect more closely the specific examples provided. However, he added, the
amendments were made without prejudice to Lilly’s right to obtain protection for
other patentable subject matter in one or more divisional applications.
79. Notwithstanding these amendments, in May 2005 the EPO examiner
formally objected to the admissibility of the new claims. He contended that the
amendments introduced subject matter beyond the content of the originally filed
documents, contrary to article 123(2) EPC 2000. Thus, he said, the inclusion in claim
1 of “use of pemetrexed …” and similar provisions in other claims did not find any
basis in the application documents as filed. According to the examiner,
“pemetrexed” was a distinct compound from pemetrexed disodium. (This is
supported by the Chemical Abstracts Service Registry, where the “pemetrexed” is
recorded as being the free diacid.) The patent does contain one mention of the term
“pemetrexed” at para [0004] of the specification, followed by a Lilly reference
number which shows it to be pemetrexed disodium. It was therefore, at best,
uncertain as to what the term “pemetrexed” on its own was intended to refer.
80. Dr Burnside replied in March 2006 by a letter under cover of which he filed
new claims, which this time were limited to pemetrexed disodium, and are now
embodied in the claims of the Patent as set out in para 21 above. Dr Burnside said:
“The Claims have been amended to refer to the preferred
embodiment, the use of pemetrexed disodium (ALIMTA®) as
manufactured by Eli Lilly and Company, as the antifolate drug.
The Claims have also been amended to incorporate the list of
vitamin B12 derivatives set out on p 7 lines 6-7 of the
application as filed.”
The EPO examiner accepted the claims in this form, and the application proceeded
to grant.
81. Actavis contends that the prosecution history, as summarised in paras 76 to
80 above, makes it clear that the claims of the Patent should be interpreted as being
limited to pemetrexed disodium not only as a matter of language, but in the sense
that the use of any other pemetrexed compound, including other pemetrexed salts
and the free acid, could not infringe. This contention gives rise to two issues. The
Page 30
first is one of relatively general application, namely whether and if so when it is
permissible to have recourse to the prosecution history of a patent when considering
whether a variant infringes that patent. The second issue is whether the prosecution
history of the Patent in this case alters the provisional conclusion reached in para 75
above.
82. So far as the first issue is concerned, Lord Hoffmann said in Kirin-Amgen
[2005] RPC 9, para 35:
“The courts of the United Kingdom, the Netherlands and
Germany certainly discourage, if they do not actually prohibit,
use of the patent office file in aid of construction. There are
good reasons: the meaning of the patent should not change
according to whether or not the person skilled in the art has
access to the file and in any case life is too short for the limited
assistance which it can provide. It is however frequently
impossible to know without access, not merely to the file but to
the private thoughts of the patentee and his advisors as well,
what the reason was for some apparently inexplicable
limitation in the extent of the monopoly claimed.”
83. In the absence of good reason to the contrary, it would be wrong to depart
from what was said by the House of Lords. It is said by Actavis that there is good
reason to depart from what Lord Hoffmann said on the ground that he was wrong in
his description of the German and Dutch approaches to this issue, and that anyway
he failed to have regard to the jurisprudence of other European courts.
84. In my view, Lord Hoffmann was right about the approach of the German and
Dutch courts to this issue. Thus, the Bundesgerichtshof, in a decision involving the
German equivalent of the instant Patent, Case No X ZR 29/15 (Eli Lilly v Actavis
Group PTC), paras 39-40, stated that “it is permissible … to use statements made
by the applicant [and the examiner] during the grant procedure as an indication of
how the person skilled in the art understands the subject matter of the patent” but
“such indications cannot be readily used as the sole basis for construction”. And in
Ciba-Geigy AG v Oté Optics BV (1995) 28 IIC 748, the Dutch Supreme Court said
that “a court will only be justified in using clarifying information from the public
part of the granting file, when it holds that even after the average person skilled in
the art has considered the description and the drawings, it is still open to question
how the contents of the claims must be interpreted”.
85. It is argued by Actavis that this limited approach to the circumstances in
which reference can be made to the prosecution file may be more restrictive than the
Page 31
approach adopted in France, Italy, and Spain, as analysed by Arnold J. Thus, he said
in para 162 of his judgment, that the Cour d’Appel observed in Case No 08/00882,
Hewlett Packard GmbH v Agilent Technologies Deutschland GmbH (27 January
2010) that “the patentee who amended its clauses to give them a limited scope may
not, without putting the safety of third parties at risk, claim that the amendments
were not necessary, nor that the limited claims have the same scope as the broader
claims”. However, the court in that case had already decided on the natural meaning
of the patent, and the contents of the file were merely being invoked to confirm the
decision. The position in Italy, according to Arnold J in para 174 of his judgment, is
that “there is no doctrine of prosecution history estoppel” and “there is no clear rule
as to the relevance, if any, of the prosecution history as an aid to the interpretation
of claims”. In Spain there is a doctrine of actos propios, which as Arnold J explained
in para 184, is “the doctrine of one’s own acts”, but it only justifies relying on the
prosecution file in relation to statements which are “unequivocal, clear, precise,
conclusive, undoubted and [do] not reflect any kind of ambiguity”.
86. While the French courts appear to be more ready to refer to the prosecution
file on issues of interpretation or scope than the German or Dutch courts, it is unclear
how much, if any, difference there is in outcome. The position in relation to the
Italian courts is more unclear, and it may well be that the effect of the approach of
the Spanish courts is the same in outcome as that of the German and Dutch courts.
In those circumstances, particularly as it may be inevitable that there is a degree of
difference in the approach of different national courts on such an issue, there is
nothing in the French, Italian, or Spanish jurisprudence which causes me to depart
from the conclusion expressed by Lord Hoffmann.
87. In my judgment, it is appropriate for the UK courts to adopt a sceptical, but
not absolutist, attitude to a suggestion that the contents of the prosecution file of a
patent should be referred to when considering a question of interpretation or
infringement, along substantially the same lines as the German and Dutch courts. It
is tempting to exclude the file on the basis that anyone concerned about, or affected
by, a patent should be entitled to rely on its contents without searching other records
such as the prosecution file, as a matter of both principle and practicality. However,
given that the contents of the file are publicly available (by virtue of article 128 EPC
2000) and (at least according to what we were told) are unlikely to be extensive,
there will be occasions when justice may fairly be said to require reference to be
made to the contents of the file. However, not least in the light of the wording of
article 69 EPC 2000, which is discussed above, the circumstances in which a court
can rely on the prosecution history to determine the extent of protection or scope of
a patent must be limited.
88. While it would be arrogant to exclude the existence of any other
circumstances, my current view is that reference to the file would only be
appropriate where (i) the point at issue is truly unclear if one confines oneself to the
Page 32
specification and claims of the patent, and the contents of the file unambiguously
resolve the point, or (ii) it would be contrary to the public interest for the contents
of the file to be ignored. The first type of circumstance is, I hope, self-explanatory;
the second would be exemplified by a case where the patentee had made it clear to
the EPO that he was not seeking to contend that his patent, if granted, would extend
its scope to the sort of variant which he now claims infringes.
89. Turning to the second issue, I do not consider that the contents of the
prosecution file in this case justify departing from the provisional conclusion
expressed in para 75 above. It seems to me clear that the reason why the examiner
considered that the claims in the patent should be limited to pemetrexed disodium
was because the teaching in the specification did not expressly extend to any other
anti-folates. It is unnecessary to decide the issue, but, at least as at present advised,
I am inclined to think that the examiner was wrong in taking that view. Indeed, in
the course of his well-presented argument for Actavis, Mr Alexander QC seemed to
accept that Lilly could have expressed its claims more widely than it did (albeit that
this was not a point which was carefully explored). However, even if the examiner
was right or at least justified in taking the stance that he did, I do not consider that
that consideration can have any bearing on the question whether any pemetrexed
salts other than pemetrexed disodium should be within the scope of the patent
pursuant to the doctrine of equivalents. The whole point of the doctrine is that it
entitles a patentee to contend that the scope of protection afforded by the patent
extends beyond the ambit of its claims as construed according to normal principles
of interpretation.
90. This point was well made by the Dutch Court of Appeals in Boston Scientific
Ireland Ltd v Cordis Europa NV 01/639 (unreported) 3 July 2003, when they held
that the contents of the prosecution file were of no assistance, as they related to a
concern which the examiner had expressed about added matter which went to
disclosure, whereas that had no relevance to the point at issue which was the scope
of the claim – which properly included equivalents.
91. I draw comfort from the fact that neither party was able to refer to a case
where a French or Spanish Court had relied upon the patentee’s response to a
disclosure or added matter objection by the examining officer as being relevant to
the scope of claim. It is true that the Madrid Appeal Court in Inmobiliaria Masife
SL v Vale y Tino SA (decision 268/2013) (unreported) 27 September 2013 held that
a patentee was bound by an exclusion which he had agreed during prosecution but
that was “to overcome an objection of the examiner based on the prior art”, a very
different point. I draw even greater comfort from the fact that the Bundesgerichtshof
reached the same conclusion on this very issue in relation to the German equivalent
of the Patent in this case in Case No X ZR 29/15 (Eli Lilly v Actavis Group PTC),
para 72.
Page 33
Direct infringement in France, Italy and Spain
92. Having concluded that the Actavis products directly infringe the Patent as a
matter of UK law, it is necessary to consider whether the same result obtains under
French, Italian and Spanish law. In my judgment, direct infringement is established
in those jurisdictions as well.
93. Turning first to French law, it appears to me that the answer to the question
of direct infringement ultimately turns on whether the Patent in this case falls into
the moyens généraux category or the moyens particuliers category, because, as
discussed in para 46 above, the doctrine of equivalents is apparently only applicable
to patent claims in the former category. With some diffidence, I have reached a
different conclusion from Arnold J on this issue and have concluded that the Patent
in this case falls into the former category. It is of course true that an appellate court
should be very slow indeed to differ from the trial judge on a question of fact.
However, the notion that the resolution of a dispute as to foreign law involves a
factual finding rather than a legal conclusion is somewhat artificial, and in any event,
the Judge did not hear any oral evidence from the expert foreign law witnesses. We
are therefore in as good a position as he was to analyse the effect of the evidence as
to foreign law.
94. The Judge considered that the Patent in this case represents a moyen
particulier, because pemetrexed disodium was the relevant means and the Patent did
not reveal it having a novel function: it merely revealed a new and better way in
which its function could be achieved. To my mind the better analysis is that the
Patent discloses that pemetrexed disodium could be used for a function for which it
could not previously have been satisfactorily or safely used in practice; specifically,
that pemetrexed disodium could be used with vitamin B12 to achieve an end which
could not have been achieved by either chemical on its own, pemetrexed disodium
because of its harmful side-effects and vitamin B12 because it would not have
worked. The essential point, as I see it, is that the Patent revealed for the first time
the existence of a combined means which functioned in a certain way, namely to
alleviate certain cancers without serious side-effects. It would be different if the
overall function of the combination of the two chemicals had not been new.
95. Support for this conclusion appears in the book referred to in para 46 above,
Droit de la propriété industrielle, whose two authors were the expert witnesses on
French law in this case. At para 719, p 443, they wrote “when the claim is over a
combination of means for which global function is novel, any combination of means
with a different structure but achieving the same global function is a priori
equivalent and thus infringing”. That passage was effectively applied by the Cour
de Cassation in Appeal P08-14741, Diffusion Equipements Loisirs v Helge, 15
September 2009.
Page 34
96. As to Italian law, Arnold J said at paras 178 and 179 of his judgment that he
had concluded that the Actavis products did not infringe the Italian designation of
the Patent on two grounds. The first (which he only accepted with “some hesitation”)
was “because on its face the patent clearly demonstrated a conscious intention of the
patentee to limit the claims to pemetrexed disodium”. The second ground was
“because if there was any doubt about that, it was amply confirmed by the
prosecution history”. It is clear that (as one would expect) the Italian courts accept
the doctrine of equivalents, and accordingly for the reasons given in paras 70 to 74
above, I would reject the first ground; and, for the reasons given in paras 91 to 93
above, I would reject the second ground also.
97. So far as Spanish law is concerned, it is common ground that the Spanish
courts have followed the United Kingdom approach, which leads to the difficult
question whether one should assume that they would follow this decision in
modifying the Improver questions and in particular the second question. I incline to
the view that judicial comity would tend to suggest that the Spanish courts would
follow this court in modifying the Improver questions, not least because this appears
to render the UK courts and therefore the Spanish courts more consistent with the
German and Dutch courts, and no more inconsistent with the French and Italian
courts.
98. In a written note dated 10 July 2017, Actavis applied for what would amount
to a reconsideration of the conclusion expressed in para 97 above, on the ground that
the reasoning of the Spanish Tribunal Supremo in the Lundbeck decision, discussed
in para 50 above, should lead to the opposite conclusion, namely that marketing
Actavis’s products in Spain would not infringe the Patent.
99. In my view, it is too late for Actavis to raise such an argument. Lilly had
sought to rely on the Lundbeck decision in its written case in this appeal, and Actavis
had objected on the ground that the decision had been given after the Court of
Appeal decision in these proceedings. It seems to me that in these circumstances it
would be wrong to permit Actavis to raise the Lundbeck decision to support their
case, especially as they are seeking to do so after knowing the result of this appeal
and the reasons for that result. I am unimpressed by Actavis’s argument that their
application is nonetheless justified because the reasoning in para 97 above was not
raised on this appeal. Actavis’s written case stated that “Spanish law has been
directly modelled on Catnic and Improver”, and in paras 182 and 187 of his
judgment on this case Arnold J effectively treated the Improver questions as part of
Spanish law. It appears to me that the conclusion that, if the UK Supreme Court
modifies the Improver questions, the Spanish courts would adopt any such
modification, was therefore within the scope of the argument raised in this Court.
Page 35
100. Furthermore, I consider that it would be wrong for Actavis to be permitted to
raise a new ground in support of their contention that their products would not
infringe in Spain, after publication of our decision, which was done with their
consent and at their instigation following receipt of our draft judgment which
concluded that their products would infringe in Spain. It is not as if Actavis had
come across new information since they had agreed to that publication. It is true
that, as explained in para 2 above, Actavis’s solicitors wrote to the Court very shortly
after they received the draft judgment, but thereafter they had nearly a full 24 hours
within which they could have withdrawn their agreement to publication of our
decision. In any event, there is obvious force in the simple point that, having agreed
to publication of the decision in advance of the handing down of the judgment, they
have to take the consequences. I do not suggest that, in every case where the decision
is published with the consent of the parties after they have seen the draft judgment,
it would be impossible for either party to invite the court to change the decision, or
any aspect of it. However, it seems to me that, in the absence of a good reason, the
interests of finality and certainty should prevail, and I do not consider that Actavis
have come up with a good enough reason in this case.
101. It is right to add that I am by no means convinced that, even if we had
permitted Actavis to re-argue their case in relation to Spain, on the basis of the
Lundbeck decision, I would have reached a different conclusion from that expressed
in para 97 above. Quite what constitutes “a degree of predictability” or “a high
probability” when it comes to assessing whether the notional addressee would
expect the variant to work must be fact-sensitive. Further, if, as seems likely but not,
I accept, certain, the German, Dutch, French and Italian courts would all hold that
Actavis’s products infringed, there would have been much to be said for the view,
which I have already expressed, that the Spanish courts would follow suit.
102. Accordingly, I would hold that the French, Italian and Spanish designations
of the Patent are also directly infringed by the Actavis products.
Indirect infringement
103. In these circumstances, Actavis’s cross-appeal, which seeks to challenge the
Court of Appeal’s conclusion that its products indirectly infringed does not, I think,
arise in the sense that it has no practical effect on the parties (other, perhaps, than on
the issue of costs). However, as the point was fully argued, gave rise to a
disagreement between the Court of Appeal and the trial judge, and can be dealt with
shortly, it is appropriate to consider it.
104. Indirect infringement is provided for in section 60(2) of the 1977 Act, and it
states that a person infringes a patent if, without the patentee’s consent, he supplies
Page 36
or offers to supply in the United Kingdom to someone not authorised by the patentee
with “any of the means, relating to an essential element of the invention, for putting
the invention into effect when he knows, or it is obvious to a reasonable person in
the circumstances, that those means are suitable for putting, and are intended to put,
the invention into effect”.
105. The reason why Lilly contends that, even if they did not directly infringe, the
Actavis products would indirectly infringe is because, when they are supplied to a
doctor or a pharmacist, they are, as Actavis would know, dissolved in a saline
solution in order to enable them to be administered to patients. Saline is a solution
of common salt, ie sodium chloride, in water, and when common salt is dissolved in
water, it separates into sodium cations and chloride anions. Accordingly, when one
of Actavis’s products, say that containing pemetrexed dipotassium, is dissolved in
saline, the solution contains pemetrexed anions and potassium cations plus sodium
cations and chloride anions. In those circumstances, argues Lilly, even if pemetrexed
dipotassium would not of itself infringe if it was administered with vitamin B12, at
least provided that the ratio of sodium ions to pemetrexed ions was at least 2:1, there
will be infringement when it is administered in saline solution, because the solution
which is administered will contain pemetrexed disodium.
106. The Court of Appeal, disagreeing with the Judge, acceded to Lilly’s argument
on this point.
107. Actavis argue that a solution consisting of, or including, pemetrexed ions and
sodium ions is not within the expression “pemetrexed disodium” in the Patent,
because it is limited to the solid, or crystalline, chemical. I agree with Floyd LJ in
rejecting that argument. There is no reason to think that the patentee intended to
limit the expression in that way; quite the contrary. It is clear that solubility was an
important issue, and indeed that was one of the two main reasons on which Actavis
rested their contention that their products did not infringe, as discussed in paras 24
to 25, 59, and 66 above. Further, and even more in point, as Floyd LJ said, in the
passages quoted in para 19 above the specification made it clear that references to
pemetrexed disodium extended to that chemical in solution.
108. Actavis also argue that there is an inconsistency between the Court of Appeal
holding, when considering direct infringement, that the notional addressee could not
be assumed to know that pemetrexed dipotassium would dissolve, and holding,
when considering indirect infringement, that pemetrexed dipotassium did in fact
dissolve. Even if I had not concluded that the notional addressee should be treated
as knowing that pemetrexed dipotassium could dissolve, I would have rejected that
argument which seems to me to involve a non-sequitur. By the time that they were
ready to market their products, Actavis knew perfectly well that they were all
soluble.
Page 37
109. Actavis further argue that a solution of pemetrexed dipotassium dissolved in
saline does not in any event contain “pemetrexed disodium” within the meaning of
that term in the Patent; it is simply pemetrexed dipotassium dissolved in saline. In
my view that is a bad point. If dissolving pemetrexed disodium in an aqueous
solution of potassium chloride can be said to result in a solution containing
pemetrexed disodium (as Actavis’s argument impliedly accepts), then it must follow
as a matter of elementary chemical logic that dissolving pemetrexed dipotassium in
saline also result in a solution which contains pemetrexed disodium: the two
solutions are chemically identical, as each would consist of potassium and sodium
cations and chloride and pemetrexed anions in water.
110. Actavis additionally argue that it is irrational to hold that there could be
indirect infringement because it would all depend on the solvent in which the
Actavis product is dissolved, and, even if that solvent was saline, it would depend
on the proportion of sodium ions and pemetrexed ions in the solution which would
vary by reference to the weight of the patient. The fact that infringement may depend
on the nature of solvent and the relative amounts of ions in the solution does not
seem to me to be irrational. It is simply a result of the extent of the scope of
protection afforded by the patent given that (as determined by the Court of Appeal)
its claims are limited to pemetrexed disodium, which, when dissolved in water
produces two sodium cations to every one pemetrexed anion.
111. Finally, Actavis argue that, rather than being used in the manufacture of a
medicament as described in claim 1 of the Patent, pemetrexed disodium is part of
the medicament. Like the Court of Appeal, I do not agree. The pemetrexed disodium
comes into the manufacturing process rather later than it would if the original
medicament included pemetrexed disodium rather than pemetrexed dipotassium, but
that cannot alter the fact that, before it is administered to the patient, the medicament
includes pemetrexed disodium and vitamin B12.
112. Accordingly, I would uphold the Court of Appeal’s determination that
Actavis are liable to Lilly for indirect infringement in the United Kingdom with
respect to their products if Actavis know, or it is obvious in the circumstances, that
ultimate users will dilute in saline – or at least Actavis would be liable for indirect
infringement if they were not liable for direct infringement. The Court of Appeal
said that this conclusion would apply equally to France, Italy, and Spain, and there
is no challenge to that from Actavis.
Conclusion
113. For these reasons, I would (i) allow Lilly’s appeal in direct infringement and
hold that the Actavis products infringe the Patent in the United Kingdom, and also
Page 38
in France, Italy and Spain, (ii) dismiss Actavis’s cross-appeal on the basis that if its
products did not directly infringe, they would indirectly infringe to the extent held
by the Court of Appeal.